HUDSON RCI COMFORT FLO Humidification System With Remote Temperature Port
Medical device recall Z-1115-2020. Published in FDA’s Enforcement Report on Feb 19, 2020.
- FDA Class I
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Feb 19, 2020. Copied from openFDA on Oct 20, 2026.
- Class I FDA’s most serious class (needs attention)
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 95696 devices how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class I, the most serious of FDA’s three classes.
“Dangerous or defective products that predictably could cause serious health problems or death. Examples include: food found to contain botulinum toxin, food with undeclared allergens, a label mix-up on a lifesaving drug, or a defective artificial heart valve.”
openFDA, in plain words, its enforcement report fields.
“Class I is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.”
FDA’s rule, 21 CFR 7.3(m)(1), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
There is the potential for water to flood the column and enter the circuit under circumstances where an abnormal pressure differential is created between the water bottle and the column during high flow oxygen therapy.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
HUDSON RCI COMFORT FLO Humidification System With Remote Temperature Port, REF 2414, humidifier nebulizer kit
95696 devices, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
GTIN 14026704659354 Lot Numbers: 74M1400307 74M1400712 74M1401529 74B1500058 74C1501166 74C1502785 74D1500015 74D1501870 74D1500696 74D1501220 74D1502153 74E1500307 74E1500858 74E1500862 74E1501080 74E1501081 74M1500348 74M1500349…
Every code shown here, 934 characters
GTIN 14026704659354 Lot Numbers: 74M1400307 74M1400712 74M1401529 74B1500058 74C1501166 74C1502785 74D1500015 74D1501870 74D1500696 74D1501220 74D1502153 74E1500307 74E1500858 74E1500862 74E1501080 74E1501081 74M1500348 74M1500349 74L1502756 74A1601231 74A1602020 74A1602926 74C1601469 74C1601958 74C1600012 74C1601957 74C1602147 74D1600255 74D1600256 74D1601787 74E1600053 74E1601254 74F1600670 74F1602336 74F1603322 74G1600072 74H1600054 74H1600053 74J1600489 74J1602064 74J1603174 74J1602868 74J1602870 74K1601772 74K1602259 74L1600134 74L1601768 74L1602603 74M1601671 74A1701896 74B1700016 74C1700027 74E1700001 74E1700934 74E1702183 74E1701545 74F1702944 74G1700799 74G1701641 74H1700405 74J1700025 74J1701885 74J1702647 74K1700429 74K1702509 74L1700956 74L1702261 74M1700484 74A1801554 74C1800450 74D1800086 74D1801078 74E1800788 74F1801158 74G1800976 74J1800380 74K1800754 74K1800571 74M1800650 74B1900012 74B1900643 74B1902468
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
nationwide
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Dec 13, 2019.
- FDA classified it on Feb 7, 2020.
- FDA’s Enforcement Report published it on Feb 19, 2020.
- FDA terminated it on Apr 30, 2024.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- TELEFLEX MEDICAL INC, of Morrisville, NC.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.